Absence of a food effect with a 145 mg nanoparticle fenofibrate tablet formulation.

Objectives: The present study was conducted to assess the effect of food on the bioavailability of fenofibric acid from a new tablet formulation containing fenofibrate nanoparticles. Methods: In this 3-way crossover study, 45 subjects received in a random order one 145 mg fenofibrate tablet under high-fat fed (HFF), low-fat fed (LFF) or fasting (reference) conditions. Plasma concentrations of fenofibric acid were determined up to 120 hours post-dose. Comparisons were made between test (HFF and LFF) and reference conditions (fasting). Results: Very close values of pharmacokinetic parameters were obtained following the three different regimens. The 90% confidence intervals (CI) for the ratio of geometric means of HFF versus fasting condition were (1.018 - 1.088) for AUC ∞ , (1.020 - 1.090) for AUC t and (0.963 -1.054) for C m a x with point estimates of 1.052, 1.054 and 1.007, respectively. The 90% CI for the geometric means of LFF versus fasting condition were (0.978 - 1.046) for AUC ∞ , (0.981-1.047) for AUC t and (0.964 - 1.055) for C m a x with point estimates of 1.012, 1.013 and 1.009, respectively. They all fall within the required limits for bioequivalence (0.80 -1.25). A slightly prolonged t m a X was observed following HFF conditions (4.3 ′ 1.9 hours, versus 3.6 ′ 1.2 hours and 2.3 ′ 0.7 hours under LFF and fasting conditions, respectively), without any effect on mean C m a x . Conclusion: The peak and overall exposures from the new 145 mg fenofibrate tablet were not affected by food. Therefore, this new fenofibrate tablet may be taken without regard to the timing of meals.